Academic CRO Strengthens Compliance
Toward the end of a long winter, an internationally renowned academic clinical institution based in Philadelphia, Pennsylvania, chose Cerulean Associates LLC to provide a full
Toward the end of a long winter, an internationally renowned academic clinical institution based in Philadelphia, Pennsylvania, chose Cerulean Associates LLC to provide a full
FDA is citing firms more and more for inadequate recordkeeping and record retention. From electronic recordkeeping systems to all paper to a hybrid reality, firms
FDA’s emphasis on data integrity and electronic record compliance causes anxiety, confusion and frustration. What is “data integrity” as it relates to day-to-day activities? to
Getting ready to submit a new medicine or product for FDA approval is a hectic, anxious time. Worry that FDA will raise questions about data
A mid-sized medical device manufacturer received an FDA warning letter. Cerulean was contacted over other consulting firms for several reasons, in the words of their
A small business supplier to the pharmaceutical and medical device industry was getting overwhelmed with demands that they be compliant with ISO, with cGMPs, and
Clinical research organizations that work with very vulnerable patient populations have to maintain the strictest confidentiality while ensuring FDA compliance and sponsor support. For one
Suppliers to pharmaceutical and medical device companies have to strike a balance between compliance for some customers while satisfying all the rest. It leads to
When it comes to records and document policies, procedures and controls, Cerulean goes beyond “best practices” to practicalities and realistic solutions. Our managing director spent
Despite all the media alerts and scare stories of executive emails coming back to haunt companies, records retention requirements are far more complicated and risky
In today’s global landscape, last century’s compliance frameworks, work flows, and SOPs serve as an anchor dragging down traditional big pharma: “Investor pressure is on
Our expertise blends with our real-world experiences being responsible for balancing budgets, achieving compliance, and ensuring efficient operations: “We’d received multiple 483s from an FDA
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